| Fixed: “Other” textbox works when documenting a study closure |
| Fixed: Documents attached to surveys included in API documentation |
| Fixed: “Confirm SSRP” step shows on To Do column of Reviewing IRB Dashboard |
| Enhanced: Updated date validation on study closure dialog |
| Fixed: One site of combo site declining engagement fully dissolves combo site |
| Fixed: Multisite Liaisons can edit/add study team members to studies |
Category Archives: FRL
New Feature: sIRB Can Close Studies on IREx
sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.
Here is what you will see for a closed study:
- Study page is grayed out with a Study Closed header at the top
- Status Summary Tab shows as Closed in Approval column
- IRB Dashboards show that a study has been closed
- Versions box shows that a study has been closed
- Exports show closed studies with date of closure
Updated Feature: Participating Site IRB Dashboard Export Renamed
The export on the Participating Site Studies dashboard has been renamed to “My Relying Studies Report” to better reflect the contents of the export for participating site HRPPs.
Bug Fixes – July 23, 2021
| Fixed: Multisite Liaison can edit previously completed HRP survey |
| Fixed: Participating Sites Removed from Study email does not send when sites with no IREx access are removed from a study |
New Feature: Survey available to request new consortiums to be added to IREx for IRB/HRPP Liaisons and Study Managers
Last month, a new feature was created to add a consortium of sites on the Participating Sites dialog so that study managers no longer have to add each site individually to their studies if the study is part of a consortium. To support this feature, we created a new survey where an IRB/HRPP Liaison or Study Manager can request a new consortium be added to IREx. The sIRB or Study Manager can also find a link to this survey on the Participating Sites dialog when they select to add a consortium.
Bug Fixes – July 6, 2021
| Fixed: Institutional Profile opens from Site-specific Approvals Tab. |
| Fixed: Documents carried over from previous approval maintain correct upload date. |
| Fixed: Site-specific Info menu shows all options for Relying HRPP liaisons. |
| Fixed: Component sites can be added to a study if the main FWA has registered for the study. |
| Fixed: Event log opens for large studies. |
| Fixed: A combo site that registers as a singular site shows as a single site on the Status Summary tab |
| Fixed: Removed error when logging in for the first time and agreeing to Terms of Use. |
| Fixed: Status Summary export shows correct LOI status for component sites. |
New Feature: Data exports for sIRBs and Relying Site HRPPs
sIRB and HRPP liaisons can now export a csv file to quickly view and analyze data for studies, including dates for registration, reliance, and approvals. The sIRB can utilize the export to evaluate processes and assess efficiency (time to approval) and workload (number of relying sites). Relying HRPPs can also export data to efficiently view all studies in which they are participating, the SIRBs serving for those studies, and dates for registration, reliance, and approvals. Access this feature through the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards under “Exports.”
Updated Feature: Capture additional timepoints during Lead & Relying Site Approvals
When capturing Lead and Relying Site Approvals, the sIRB and SM can now capture additional timepoints in the review process, such as the date the sIRB requested changes from PI and when those changes were received. Additional IRB review dates can also be captured if a study required multiple reviews. Local Review dates have been moved to the HRP survey for studies capturing Local Considerations to streamline the date capture. Local review dates have been removed for studies not capturing Local Considerations, since those sIRBs have chosen to track local considerations outside of IREx. The Status Summary Tab export, Reviewing Site Dashboard export, and Participating Site dashboard include these additional fields. These additional dates are optional but may help in achieving a more granular timeline of the sIRB review process.
Updated Feature: Enhancements to sIRB and Participating Studies Dashboards
Filters have been added to Reviewing Site’s Studies and Participating Site’s Studies dashboards to refine the studies viewed. The sIRB can filter their Reviewing Site’s Studies to only view Ongoing Studies, hiding studies where all sites have a current approval. Furthermore, IRBs/HRPPs in the Trials Innovation Network (TIN) can filter by TIN Only studies and non-TIN only studies.
The Participating Site Dashboard now shows the Local IRB Number, which is an optional field on the HRP survey filled out by the Relying Site HRPP. This same number can also be viewed in the Site-Specific Approvals tabs.
The Participating Site Dashboard now shows the date the IRB approved the site under “To Do”
These enhancements were added for quick viewing and efficient searching.
Updated Feature: Enhancements to the Agreement Checker
The Agreement Checker is a helpful tool on the IREx homepage which helps see if potential sites have already executed reliance and broad indemnification emails for a selected sIRB. We have made enhancements to make this tool easier to use and more visually appealing. There is added informational text explaining that sites are only required to execute one reliance agreement offered on a study, even if they have executed multiple. The SMART 1, SMART 2, and Other Reliance columns have been shaded to show that all are considered a reliance agreement. The Other Reliance Agreement and Indemnification columns have been updated with an easy-to-spot ✔️check mark symbol. The csv export includes the full FWA number.